Method and System for Automatically Tracking and Enforcing Compliance and Version Control of regulatory training for Clinical Trials

ABSTRACT

The invention provides a system that manages version changes of regulatory training and update training plans for those users who are affected by the change based on a set of rules defined by the clinical trial sponsor. The system also provides custom updated training plans when different sponsors have different rules affecting regulatory training updates.

RELATED APPLICATIONS

This application is related to U.S. provisional application 61/595,613,filed Feb. 6, 2012, and the entirety of said application is incorporatedby reference as if fully set forth herein. This application is alsorelated to U.S. provisional application 61/595,378 filed Feb. 6, 2012,and the entirety of said provisional application is incorporated byreference as if fully set forth herein. This application is also relatedto U.S. provisional application 61/654,915, filed Jun. 3, 2012, theentirety of which is incorporated by reference as if fully set forthherein. This application is also related to U.S. patent application Ser.Nos. 12/452,363; 12/449,791; 13/622,519, the entirety of each of whichis incorporated by reference as if fully set forth herein.

FIELD OF USE

The invention is useful in the field of clinical trial management, andmore specifically in the field of clinical trial physician and stafftraining record management in support of clinical trials.

BACKGROUND

Clinical trial sponsors (Sponsors) commonly make available to clinicaltrial participating physicians or staff personnel (Users) onlinetraining in regulatory subjects, referred to herein as “regulatorytraining”. Regulatory subjects typically includes subjects such as GoodClinical Practice, Serious Adverse Events, Informed Consent Process,Product Complaint Procedure, Privacy, and other topics that arefoundational to the conduct of clinical trials and are the same acrossall trials. A Sponsor typically maintains versions of these regulatorytraining subjects. Users are required to periodically update theirregulatory training at scheduled intervals.

Online training systems also commonly provide a standard library ofregulatory training modules. For a given clinical trial, an onlinetraining system tracks User completion of these modules and the versionnumber of the module completed. Such online training systems typicallyprovide for cross-trial credit for these regulatory training topics.When the User training credential “expires”, the User must repeat theregulatory training module to obtain current certification.

From time to time, changes are promulgated in regulatory subjects andconsequently, changes are introduced into regulatory subject trainingThe clinical trial Sponsor is responsible for updating regulatorytraining and will release updates to the regulatory training modules atvarious intervals. Some of the updates are minor changes which areconsidered to be “equivalent” to the old training with someimprovements, and re-training is not required of Users with unexpiredtraining credentials. However, some of the updates are major changeswhich require retraining of physicians and site support personnel, andre-training must be completed by those who are currently involved in aclinical trial or who are about to participate in a clinical trial.

Currently, there is no method for implementing version changes in a waythat is consistent across the organization and are applied automaticallyto users at the time of the version release. Sponsors of clinical trialsrequire some method for automatically managing the release of updatesfor regulatory training Each sponsor may have different requirementswhen updates are released and minor and major releases may also behandled differently across sponsors. Currently, there is no way toensure that the rules regarding these updates are managed across theenterprise.

For example, Sponsor X may require that new users who have not taken theprevious version must take the most up-to-date training when they starta clinical trial. Existing users who have taken the previous version arenot required to update their training if the update is a minor change.When they go to their next study will they be required to take theupdated training However, Sponsor Y may not require a user to re-trainuntil the expiration date of their current training Each Sponsor mayhave different requirements about re-training

For the same Sponsor, X, a major change to a regulatory training modulerequires that all users, regardless of whether they have taken aprevious version be required to update their training to the latestversion at the time the version is released. For Sponsor X, even thosewho are already in a clinical trial, the requirement is to re-train atthe time the new version of the regulatory training is released.

However, the rules regarding this may be different across sponsor;Sponsor Y sponsors may not require a re-training until the user startstheir next trial.

What is needed is a system to manage version changes of regulatorytraining and update training plans for those users who are affected bythe change based on a set of rules defined by the relevant sponsor orsponsors of clinical trials.

BRIEF SUMMARY OF THE INVENTION

The invention provides a solution to at least all the abovementionedunmet needs. A system according to the invention manages version changesof regulatory training and update training plans for those users who areaffected by the change based on a set of rules defined by the sponsor.The system also provides custom updated training plans where differentsponsors have different rules affecting regulatory training updates.

It can be appreciated that any embodiment of a system implementing thisinvention will use a central processing unit, a memory device, dataentry units, and reporting units, as are depicted in the figuresaccompanying this specification. All of the hardware elements of such asystem, as well as the function of software, computer implementableinstructions, are familiar to one of average skill in the relevant art.

The system allows a set of rules to be put into place for minor andmajor changes to regulatory modules. The rules can be as complex asrequired and include many different variables such as the type of update(minor or major), whether or not users who have been trained on aprevious version must update their training for existing trials or onlyfor new trials, the date on which the update comes into effect, trialswhich are excluded from the update, etc.

Regulatory training modules are designated as such in order todifferentiate them from all of the other types of clinical trialtraining such as protocol specific training Version numbers are assignedto these modules and controlled in order to maintain the integrity ofthe system.

When a version change for a regulatory module is released by thesponsor, the system automatically applies the training rules to therelease. The system evaluates the training profiles for all of thephysicians and site support personnel who are currently involved inclinical trials. Physicians and site support personnel who join afterthe update is completed are also be affected by the rules that apply tothe version change.

In one embodiment of the invention, the invention further provides anoptimal training requirement satisfaction determination for anypotential clinical trial staff, including but not limited to physicians.For any clinical trial, the optimal training schedule for a potentialstaff member, where such an optimal training schedule take into accountthe staff personal training record, requirements already satisfied, aswell as the variety of training options available for remainingrequirements yet to be satisfied. Such an optimized training scheduleprovides for accurate record of requirements already satisfied, therebyeliminating training redundancies. Moreover, such a system provides themost efficient satisfaction of any remaining training requirements,ensuring as rapid and efficient as possible staff qualification toparticipate in the clinical trial. Such an optimized and personalizedtraining protocol further aids in the rapid commencement of site andpersonnel qualification, while maintaining auditable records for use bythe trial Sponsor.

In one embodiment of the invention, the Sponsor can publish a list oftraining options and venues and allow the physician and site supportstaff to select the optimal training option based on their schedules andother commitments. Alternatively, the physician or staff can query theonline training system to print out one's own training record, and anoptimized potential training regimen from the training options availablefor to be satisfied training requirements. In this way, the inventionprovides a personalized, optimized training program for the clinicaltrial of interest.

BRIEF DESCRIPTION OF THE DRAWINGS

Drawings to aid in the understanding of the invention are:

FIG. 1 is illustrative of a system for tracking online trainingaccording to the invention.

FIG. 2 illustrates an exemplar training profile according to theinvention.

FIG. 3 illustrates an application of version change to Good ClinicalPractice regulatory training module and depicts the application of a setof rules for re- training

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

It can be appreciated without the need for further elaboration, that asystem according to the invention does necessarily include input andoutput devices connected to or networked with a main computer, where themain computer has at least one Central Processing Unit (CPU), a memoryand storage module, processing capabilities, and instructionsimplementable by the computer (software or firmware) to perform all thefunctions described herein. The inventive method is comprised of stepsusing input devices for inputting data, storing data, processing data,and outputting data, where interaction with the system is generallyaccomplished via one or more graphical user interfaces.

A person of average skill in the relevant art requires no specialexplanation to to comprehend how the invention works. Some generalizedexamples are depicted in the figures filed herewith, and discussed laterherein. More discussion of the system depicted in FIGS. 1 and 2, appearsin patent application entitled “Automated collection and aggregation ofcross-platform and live event or in-person training records to supportthe conductance of clinical trials”, docket TRI007, filed Feb. 3, 2013,by inventors Alden Meier and Dave Young.

The below description can be understood along with reference to FIG. 3,and the reader can appreciate the utility of the invention taughtherein. Although FIG. 3 depicts “physician” training, any clinical trialstaff requiring training falls within the intended scope of theinvention.

The discussion herein focuses on an example of the inventive utility.

Example One

A clinical trial is initiated by a sponsor, whom we shall denominate“Sponsor X”. Sponsor X is using the current standard regulatory modules.One of the training modules, Good Clinical Practice (GCP) is currentlyat version 1.0 (in FIG. 3, (GCP) (V1.0). The duration for training onGCP is customarily two years-normally a physician need only re-train inGCP every 2 years (or 24 months).

GCP Version 1.1. Six months after the trial starts, a minor update tothe GCP training is released and the new version is GCP V 1.1. Referringto the time line depicted in FIG. 3, it can be seen that at the left,“start of trial” and proceeding to the right, “6 months”, “1 year”, “2years”, “3 years” and “4 years”. Referring to FIG. 3, on the bottom: At“6 months” GCP Training Updated to Version 1.1 (Minor Change); at thetop: Month 6: A minor release to GCP is implemented by the Sponsororganization. All new users must take this version. Since it is a minorchange, all physicians who have taken 1.0 do not have to that the newtraining is they are on an existing trial.”

Physician 1 (depicted in the upper left of FIG. 3) starts the trial atthe beginning of the trial, and takes GCP V 1.0. It is good for 2 years,so for a minor change, no retraining is required.

Physician 2 starts the trial at month 7, and has not taken GCPpreviously, therefore physician 2 must train GCP V 1.1.

Sponsor X has determined that the rules for GCP will be as follows:

-   -   1. All users who have taken version 1.0 within the past two        years do not need to take the 1.1 training for the remainder of        any trials they are currently working on and will not be        required to retrain on version 1.1 if they join a new trial        within the two year period.    -   2. All new users who have not taken the GCP training within the        past two years must take the 1.1 version before they can start        working on the trial.

Sponsor X determines the release date for the change and the systemautomatically updates the training for all trials and makes version 1.1the new requirement for all new participants on that date. Users whohave started a trial and have taken training on version 1.0 are notrequired to retrain.

As depicted in FIG. 3, the rules apply to physician 1 and physician 2.

GCP Version 2.0. Two years into the same trial, Sponsor X releases amajor change to the GCP training (GCP version 2.0) to addressperformance issues on their clinical trials. In this case, Sponsor Xdecides that all physicians and site support staff must take the newtraining, regardless of the version of their previous training or whenthey took it. Sponsor X again determines the release date for the changeand the system automatically updates the training for all trials andmakes version 2.0 the new requirement for all participants, includingeveryone who has trained on any previous version. All users have theirtraining status updated and must complete the version 2.0 training inorder to continue to work on the trial. The new training is good for twoyears before retraining is required.

Referring again to FIG. 3, the effect of GCP version 2.0 and the rulesset by Sponsor X are depicted, illustrating how the effect plays out forthe training requirements of physicians 1, physician 2, and anadditional physician 3.

All three physician are required to retrain on GCP version 2.0,regardless of time since last training or version of last training onGCP.

It can be appreciated that the invention provides for proper tracking ofminor versions, allowing for training credit to be applied and avoidingunnecessary re-training This was illustrated in the case of physician 1in FIG. 3.

The invention further provides for organization wide implementation ofchanges by virtue of changing training status of all users according torules set, and tracking compliance with the rules. As illustrated inFIG. 3, where significant changes are made (ex. GCP version 2.0), allphysicians are required to re-train on GCP 2.0, and the inventionprovides for notice of the training requirement, as well as keepingrecord of compliance. For quality control in large clinical trials, suchauditable tracking of training and compliance is essential.

It is to be understood that the invention can further reconcile ruledifferences between different sponsors with respect to regulatorytraining and cross-credit. Moreover, the invention provides, in oneembodiment, an optimal training option to users. Thus, not only is thetraining status of Users tracked closely, the re-training requirementsof the users are distilled into a “best fit” list of re-trainingoptions. Again, the implementation of such an output report, in light ofthe system components and functions as generally understood, needs nofurther explanation.

We claim:
 1. An improved system for tracking and enforcing complianceand version control of regulatory training for clinical trials, in anetworked system, said system comprised of at least one computingdevice, central processing unit, memory and storage, and computerimplementable instructions for accomplishing data storage, maintenanceand analysis, and input and output devices, said input and outputdevices connected to user interfaces, where said improvement comprises:computer implementable instructions, said instructions expressing rulesto manage version changes of regulatory training and update trainingplans for those users who are affected by said version change ofregulatory training; and monitoring training status of all users, sothat said clinical trial records of regulatory training compliance arecomprehensive and accurate.
 2. An improved method for tracking andenforcing compliance and version control of regulatory training forclinical trials, where said improvement comprises the steps of:directing an online training system, where said system is comprised ofat least one computing device, central processing unit, memory andstorage, and computer implementable instructions for accomplishing datastorage, maintenance and analysis, and input and output devices, saidinput and output devices connected to user interfaces, to apply rulesregarding regulatory training to user profiles, where said user profilesare stored in memory and include user training status data, such thatsaid system outputs an updated user training status.